FDA 483 - Sigma-Aldrich Manufacturing LLC - April 28, 2025

An FDA inspection of Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, a human drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate manufacturing deviations, including repeat observations, and lacked appropriate specifications and risk assessments for nonsterile APIs. Additionally, computerized systems allowed unauthorized data alteration, and process validation activities were found to be scientifically inadequate.